EpiCept is testing its NP-1 drug for use in two different indications and believes it has the largest market potential of any of its pain product candidates. EpiCept said the results of these trials are intended to broaden NP-1's labeling within peripheral neuropathies and raise the product candidate's future market potential.
The first phase IIb trial is intended to confirm and expand upon earlier work on a smaller scale which provided an efficacy signal in this type of neuropathic pain. Only two medications are currently approved for neuropathic pain. The primary endpoint for this trial is the change in pain intensity over the four week duration of the trial. Preliminary results are expected by the fourth quarter of 2007.
The second trial will test the drug in peripheral herpetic neuropathy (PHN). This trial will compare the efficacy and safety of the drug compared to gabapentin as well as placebo. NP-1 has already shown in a prior phase II dose ranging study a pronounced efficacy signal in this type of neuropathic pain.
This active comparator trial is one of the first such efforts to examine any candidate compound at this scale in neuropathic pain. The primary endpoint for this trial is the change in pain intensity over the four week duration of the trial. Preliminary results are expected in the first quarter of 2008.